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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION OPTEASE IVC FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CORPORATION OPTEASE IVC FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Bone Fracture(s) (1870)
Event Date 07/16/2020
Event Type  Injury  
Event Description

Optease ivc filter found to be fractured with broken piece retained locally and intravascular in ivc. Removed both in complex removal procedure today. Fda safety report id #: (b)(4).

 
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Brand NameOPTEASE IVC FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
miami lakes FL
MDR Report Key10295397
MDR Text Key199735000
Report NumberMW5095601
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 07/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/17/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 07/17/2020 Patient Sequence Number: 1
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